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"The Effects of Gingivoperiosteoplasty and Cleft Palate Repair on Facial Growth."

Park, Jenn J; Kalra, Aneesh; Parsaei, Yassmin; Rochlin, Danielle H; Verzella, Alexandra; Grayson, Barry H; Cutting, Court B; Shetye, Pradip R; Flores, Roberto L
PURPOSE/OBJECTIVE:Gingivoperiosteoplasty (GPP) can avoid secondary alveolar bone graft in up to 60% of patients. The effects of GPP on maxillary growth are a concern. However, palatoplasty can also negatively impact facial growth. This study quantifies the isolated effects of GPP and cleft palate repair on maxillary growth at the age of mixed dentition. METHODS:A single institution, retrospective study of all patients undergoing primary reconstruction for unilateral cleft lip and alveolus (CLA) or cleft lip and palate (CLP) was performed. Study patients had lateral cephalograms at age of mixed dentition. Patients were stratified into four groups: CLA with GPP (CLA+GPP), CLA without GPP (CLA-GPP), CLP with GPP (CLP+GPP), and CLP without GPP (CLP-GPP). Cephalometric measurements included: sella-nasion-point A (SNA), sella-nasion-point B (SNB), and A point-nasion-B point (ANB). Landmarks were compared between patient groups and to Eurocleft Center D data. RESULTS:110 patients met inclusion criteria: 7 CLA-GPP, 16 CLA+GPP, 24 CLP-GPP, and 63 CLP+GPP patients. There were no significant differences in SNA, SNB, and ANB between CLA+GPP and CLA-GPP, or between CLP+GPP and CLP-GPP groups. In patients who did not receive GPP, SNA was significantly lower in patients with a cleft palate compared to patients with an intact palate (p < 0.05). There were no significant differences in SNA or SNB of CLP-GPP or CLP+GPP groups when compared to Eurocleft data. CONCLUSION/CONCLUSIONS:When controlling for the effects of cleft palate repair, GPP does not appear to negatively affect midface growth at the age of mixed dentition.
PMID: 37184473
ISSN: 1529-4242
CID: 5544102

Virtual Reality Simulation of Airway Management Post-Cleft Palate Surgery: A Model for Sustainable and Equitable Education

Verzella, Alexandra N; Diaz, Allison L; Laspro, Matteo; Alcon, Andre; Schechter, Jill; Oliker, Aaron; Arnold, Anne; Flores, Roberto L
BACKGROUND:The effectiveness of virtual-reality (VR) simulation-based training in cleft surgery has not been tested. The purpose of this study was to evaluate learners' acceptance of VR simulation in airway management of a pediatric patient post-cleft palate repair. METHODS:This VR simulation was developed through collaboration between BioDigital and Smile Train. 26 medical students from a single institution completed 10 min of standardized VR training and 5 min of standardized discussion about airway management post-cleft palate repair. They spent 4-8 min in the VR simulation with guidance from a cleft surgery expert. Participants completed pre- and post-surveys evaluating confidence in using VR as an educational tool, understanding of airway management, and opinions on VR in surgical education. Satisfaction was evaluated using a modified Student Evaluation of Educational Quality questionnaire and scored on a 5-point Likert scale. Wilcoxon signed-rank tests were performed to evaluate responses. RESULTS: < .001). Respondents' opinions on incorporating VR in surgical education started high and did not change significantly post-simulation. Participants were satisfied with VR-based simulation and reported it was stimulating (4.31 ± 0.88), increased interest (3.77 ± 1.21), enhanced learning (4.12 ± 1.05), was clear (4.15 ± 0.97), was effective in teaching (4.08 ± 0.81), and would recommend the simulation (4.2 ± 1.04). CONCLUSION/CONCLUSIONS:VR-based simulation can significantly increase learners' confidence and skills in airway management post-cleft palate repair. Learners find VR to be effective and recommend its incorporation in surgical education.
PMID: 38545670
ISSN: 1545-1569
CID: 5645072

Abbe Flap Division Before Two Weeks"™ Time: Harmful or Advantageous?

Muller, John N.; Diaz, Allison; Flores, Roberto L.; Staffenberg, David A.
Introduction: The Abbe flap is a standard intervention to treat upper lip deformities in patients with bilateral cleft lip. This two-stage procedure requires a 2 to 3-week period in which the superior and inferior lips remain connected. This study evaluates the safety of Abbe flap division and inset prior to 14 days"™ time. Materials and Methods: A single institution, 8-year review of all patients with a bilateral cleft lip who underwent Abbe flap reconstruction was performed. Patients were classified into two groups: those whom division was performed 14 days or later and those with division earlier than 14 days. Results: A total of 26 patients were identified. Patients who underwent Abbe flap division in less than 14 days (n = 10) demonstrated an average time to division of 9.7 days (range 7"“13 days) with no evidence of flap loss, wound breakdown or infection. Patients who underwent Abbe flap division within 14 days or more (n = 16) demonstrated an average time to division of 15 days with four minor complications and no flap loss. Conclusion: Dividing the Abbe flap after the first postoperative week appears to be safe and without additional risk to flap loss or wound breakdown. A shorter time to Abbe flap division may decrease the burden of care on patients and their caregivers.
ISSN: 1055-6656
CID: 5630222

Direct inkjet writing type 1 bovine collagen/β-tricalcium phosphate scaffolds for bone regeneration

Cabrera Pereira, Angel; Tovar, Nick; Nayak, Vasudev Vivekanand; Mijares, Dindo Q; Smay, James E; Torroni, Andrea; Flores, Roberto L; Witek, Lukasz
Bone tissue has the capacity to regenerate under healthy conditions, but complex cases like critically sized defects hinder natural bone regeneration, necessitating surgery, and use of a grafting material for rehabilitation. The field of bone tissue engineering (BTE) has pioneered ways to address such issues utilizing different biomaterials to create a platform for cell migration and tissue formation, leading to improved bone reconstruction. One such approach involves 3D-printed patient-specific scaffolds designed to aid in regeneration of boney defects. This study aimed to develop and characterize 3D printed scaffolds composed of type I collagen augmented with β-tricalcium phosphate (COL/β-TCP). A custom-built direct inkjet write (DIW) printer was used to fabricate β-TCP, COL, and COL/β-TCP scaffolds using synthesized colloidal gels. After chemical crosslinking, the scaffolds were lyophilized and subjected to several characterization techniques, including light microscopy, scanning electron microscopy, and x-ray diffraction to evaluate morphological and chemical properties. In vitro evaluation was performed using human osteoprogenitor cells to assess cytotoxicity and proliferative capacity of the different scaffold types. Characterization results confirmed the presence of β-TCP in the 3D printed COL/β-TCP scaffolds, which exhibited crystals that were attributed to β-TCP due to the presence of calcium and phosphorus, detected through energy dispersive x-ray spectroscopy. In vitro studies showed that the COL/β-TCP scaffolds yielded more favorable results in terms of cell viability and proliferation compared to β-TCP and COL scaffolds. The novel COL/β-TCP scaffold constructs hold promise for improving BTE applications and may offer a superior environment for bone regeneration compared with conventional COL and β-TCP scaffolds.
PMID: 38247237
ISSN: 1552-4981
CID: 5624542

The Use of Virtual Reality in Surgical Training: Implications for Education, Patient Safety, and Global Health Equity

Laspro, Matteo; Groysman, Leya; Verzella, Alexandra N.; Kimberly, Laura L.; Flores, Roberto L.
As medicine becomes more complex, there is pressure for new and more innovative educational methods. Given the economic burden associated with in-person simulation, healthcare, including the realm of surgical education, has begun employing virtual reality (VR). Potential benefits of the addition of VR to surgical learning include increased pre-operative resident exposure to surgical techniques and procedures and better patient safety outcomes. However, these new technological advances, such as VR, may not replicate organic tissues or accurately simulate medical care and surgical scenarios, creating unrealistic pseudo-environments. Similarly, while advancements have been made, there are ongoing disparities concerning the utilization of these technologies. These disparities include aspects such as the availability of stable internet connections and the cost of implementing these technologies. In accordance with other innovative technologies, VR possesses upfront economic costs that may preclude equitable use in different academic centers around the world. As such, VR may further widen educational quality between high- and low-resource nations. This analysis integrates recent innovations in VR technology with existing discourse on global health and surgical equality. In doing so, it offers preliminary guidance to ensure that the implementation of VR occurs in an equitable, safe, and sustainable fashion.
ISSN: 2673-4095
CID: 5630592

Clinical Outcomes of Bilateral Cleft Lip and Palate Repair with Nasoalveolar Molding and Gingivoperiosteoplasty to Facial Maturity

Rochlin, Danielle H; Park, Jenn; Parsaei, Yassmin; Kalra, Aneesh; Staffenberg, David A; Cutting, Court B; Grayson, Barry H; Shetye, Pradip R; Flores, Roberto L
BACKGROUND:The long-term effects of nasoalveolar molding (NAM) on patients with bilateral cleft lip and palate (BCLP) are unknown. The authors report clinical outcomes of facially mature patients with complete BCLP who underwent NAM and gingivoperiosteoplasty (GPP). METHODS:A single-institution retrospective study of nonsyndromic patients with complete BCLP who underwent NAM between 1991 and 2000 was performed. All study patients were followed to skeletal maturity, at which time a lateral cephalogram was obtained. The total number of cleft operations and cephalometric measures was compared with a previously published external cohort of patients with complete and incomplete BCLP in which a minority (16.7%) underwent presurgical orthopedics before cleft lip repair without GPP. RESULTS:Twenty-four patients with BCLP comprised the study cohort. All patients underwent GPP, 13 (54.2%) underwent alveolar bone graft, and nine (37.5%) required speech surgery. The median number of operations per patient was five (interquartile range, two), compared with eight (interquartile range, three) in the external cohort ( P < 0.001). Average age at the time of lateral cephalogram was 18.64 years (1.92). There was no significant difference between our cohort and the external cohort with respect to sella-nasion-point A angle (SNA) [73 degrees (6 degrees) versus 75 degrees (11 degrees); P = 0.186] or sella-nasion-point B angle (SNA) [78 degrees (6 degrees) versus 74 degrees (9 degrees); P = 0.574]. Median ANB (SNA - SNB) was -3 degrees (5 degrees) compared with -1 degree (7 degrees; P = 0.024). Twenty patients (83.3%) underwent orthognathic surgery. CONCLUSION:Patients with BCLP who underwent NAM and GPP had significantly fewer total cleft operations and mixed midface growth outcomes at facial maturity compared with patients who did not undergo this treatment protocol. CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, III.
PMID: 36943703
ISSN: 1529-4242
CID: 5590622

LeFort I Horizontal Osteotomy: Defining the Feasibility of the "High Osteotomy"

Verzella, Alexandra N; Alcon, Andre; Schechter, Jill; Shetye, Pradip R; Staffenberg, David A; Flores, Roberto L
OBJECTIVE:To define "high osteotomy" and determine the feasibility of performing this procedure. DESIGN/METHODS:Single institution, retrospective review. SETTING/METHODS:Academic tertiary referral hospital. PATIENTS, PARTICIPANTS/METHODS:34 skeletally mature, nonsyndromic patients with unilateral CLP who underwent Le Fort I osteotomy between 2013 and 2020. Patients with cone-beam computed tomography (CBCT) scans completed both pre- (T1) and post-operatively (T2) were included. Patients with bilateral clefts and rhinoplasty prior to post-operative imaging were excluded. INTERVENTIONS/METHODS:Single jaw one-piece Le Fort I advancement surgery. MAIN OUTCOME MEASURES/METHODS:Measurements of the superior ala and inferior turbinates were taken from the post-operative CBCT. RESULTS:The sample included 26 males and 8 females, 12 right- and 22 left-sided clefts. The inferior turbinates are above the superior alar crease at a rate of 73.53% and 76.48% on the cleft and non-cleft sides, respectively. One (2.9%) osteotomy cut was above the level of the cleft superior alar crease, and no cuts were above the level of the non-cleft superior ala. On average, the superior ala was 2.63 mm below the inferior turbinates. The average vertical distances from the superior alar crease and the inferior turbinates to the base of the non-cleft side pyriform aperture were 12.17 mm (95% CI 4.00-20.34) and 14.80 mm (95% CI 4.61-24.98), respectively. To complete a "high osteotomy," with 95% confidence, the cut should be 20.36 mm from the base of the pyriform aperture. CONCLUSIONS:A "high" osteotomy is not consistently possible due to the relationship between the superior alar crease and the inferior turbinate.
PMID: 37885216
ISSN: 1545-1569
CID: 5614352

The Reality of Commercial Payer-Negotiated Rates in Cleft Lip and Palate Repair

Rochlin, Danielle H; Rizk, Nada M; Flores, Roberto L; Matros, Evan; Sheckter, Clifford C
BACKGROUND:Commercial payer-negotiated rates for cleft lip and palate surgery have not been evaluated on a national scale. The aim of this study was to characterize commercial rates for cleft care, both in terms of nationwide variation and in relation to Medicaid rates. METHODS:A cross-sectional analysis was performed of 2021 hospital pricing data from Turquoise Health, a data service platform that aggregates hospital price disclosures. The data were queried by CPT code to identify 20 cleft surgical services. Within- and across-hospital ratios were calculated per CPT code to quantify commercial rate variation. Generalized linear models were used to assess the relationship between median commercial rate and facility-level variables and between commercial and Medicaid rates. RESULTS:There were 80,710 unique commercial rates from 792 hospitals. Within-hospital ratios for commercial rates ranged from 2.0 to 2.9 and across-hospital ratios ranged from 5.4 to 13.7. Median commercial rates per facility were higher than Medicaid rates for primary cleft lip and palate repair ($5492.20 versus $1739.00), secondary cleft lip and palate repair ($5429.10 versus $1917.00), and cleft rhinoplasty ($6001.00 versus $1917.00; P < 0.001). Lower commercial rates were associated with hospitals that were smaller ( P < 0.001), safety-net ( P < 0.001), and nonprofit ( P < 0.001). Medicaid rate was positively associated with commercial rate ( P < 0.001). CONCLUSIONS:Commercial rates for cleft surgical care demonstrated marked variation within and across hospitals, and were lower for small, safety-net, or nonprofit hospitals. Lower Medicaid rates were not associated with higher commercial rates, suggesting that hospitals did not use cost-shifting to compensate for budget shortfalls resulting from poor Medicaid reimbursement.
PMID: 36847669
ISSN: 1529-4242
CID: 5606542

"Bone Tissue Engineering in the Growing Calvaria: A 3D Printed Bioceramic Scaffold to Reconstruct Critical-Sized Defects in a Skeletally Immature Pig Model"

DeMitchell-Rodriguez, Evellyn M; Shen, Chen; Nayak, Vasudev V; Tovar, Nick; Witek, Lukasz; Torroni, Andrea; Yarholar, Lauren M; Cronstein, Bruce N; Flores, Roberto L; Coelho, Paulo G
BACKGROUND:3D-printed bioceramic scaffolds composed of 100% beta(β)-tricalcium phosphate augmented with dipyridamole (3DPBC-DIPY) can regenerate bone across critically sized defects in skeletally mature and immature animal models. Prior to human application, safe and effective bone formation should be demonstrated in a large translational animal model. This study evaluated the ability of 3DPBC-DIPY scaffolds to restore critically sized calvarial defects in a skeletally immature, growing minipig. METHODS:Unilateral calvarial defects (~1.4cm) were created in six-week-old Göttingen minipigs (n=12). Four defects were filled with a 1000µ M 3DPBC-DIPY scaffold with a cap (a solid barrier on the ectocortical side of the scaffold to prevent soft tissue infiltration), four defects were filled with a 1000µM 3DPBC-DIPY scaffold without a cap, and four defects served as negative controls (no scaffold). Animals were euthanized 12-weeks post-operatively. Calvaria were subjected to micro-computed tomography, 3D-reconstruction with volumetric analysis, qualitative histologic analysis, and nanoindentation. RESULTS:Scaffold-induced bone growth was statistically greater than negative controls (p≤0.001) and the scaffolds with caps produced significantly more bone generation compared to the scaffolds without caps (p≤0.001). Histological analysis revealed woven and lamellar bone with the presence of haversian canals throughout the regenerated bone. Additionally, cranial sutures were observed to be patent and there was no evidence of ectopic bone formation or excess inflammatory response. Reduced elastic modulus (Er) and hardness (H) of scaffold-regenerated bone were found to be statistically equivalent to native bone (p = 0.148 for Er of scaffolds with and without caps, and p = 0.228 and p = 0.902, for H of scaffolds with and without caps, respectively). CONCLUSION/CONCLUSIONS:3DPBC-DIPY scaffolds have the capacity to regenerate bone across critically sized calvarial defects in a skeletally immature translational pig model.
PMID: 36723712
ISSN: 1529-4242
CID: 5420092

Three-Dimensional Printing Bioceramic Scaffolds Using Direct-Ink-Writing for Craniomaxillofacial Bone Regeneration

Nayak, Vasudev Vivekanand; Slavin, Blaire V; Bergamo, Edmara T P; Torroni, Andrea; Runyan, Christopher M; Flores, Roberto L; Kasper, F Kurtis; Young, Simon; Coelho, Paulo G; Witek, Lukasz
Defects characterized as large osseous voids in bone, in certain circumstances, are difficult to treat, requiring extensive treatments which lead to an increased financial burden, pain, and prolonged hospital stays. Grafts exist to aid in bone tissue regeneration (BTR), among which ceramic-based grafts have become increasingly popular due to their biocompatibility and resorbability. BTR using bioceramic materials such as β-tricalcium phosphate has seen tremendous progress and has been extensively used in the fabrication of biomimetic scaffolds through the three-dimensional printing (3DP) workflow. 3DP has hence revolutionized BTR by offering unparalleled potential for the creation of complex, patient, and anatomic location-specific structures. More importantly, it has enabled the production of biomimetic scaffolds with porous structures that mimic the natural extracellular matrix while allowing for cell growth-a critical factor in determining the overall success of the BTR modality. While the concept of 3DP bioceramic bone tissue scaffolds for human applications is nascent, numerous studies have highlighted its potential in restoring both form and function of critically sized defects in a wide variety of translational models. In this review, we summarize these recent advancements and present a review of the engineering principles and methodologies that are vital for using 3DP technology for craniomaxillofacial reconstructive applications. Moreover, we highlight future advances in the field of dynamic 3D printed constructs via shape-memory effect, and comment on pharmacological manipulation and bioactive molecules required to treat a wider range of boney defects.
PMID: 37463403
ISSN: 1937-3392
CID: 5535642